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Implementation of Clinical Triggers for Palliative Care Consultation on the Edward Hines Jr. VA Hematology/ Oncology Inpatient Service
Purpose
Hospitalized patients with advanced malignancies often have high symptom burden and poor quality of life, which are frequently under-recognized or under-treated. Accordingly, the integration of specialty palliative care (PC) in this population is imperative. Unfortunately, a sustainable referral model to capture patients for timely PC involvement is lacking. This quality improvement study evaluated the implementation of a clinical trigger-based referral process to PC for inpatients on the Hematology/Oncology (HO) service at Hines VA Hospital. Clinical outcomes studied included: Life-Sustaining Treatment (LST) note completion rates; measurement of overall survival at 3, 6, and 12 months; rate of re-hospitalization within 30 days; and venue of death and treating specialty of deceased patients.
Methods
House staff received a weekly email that included the clinical PC triggers. Admitted patients who met trigger criteria would prompt consultation to PC. Clinical triggers included: metastatic oncologic disease or relapsed hematologic disease; uncontrolled symptoms; > 2 unscheduled hospitalizations in the prior 30 days; and unscheduled hospitalizations lasting > 7 days.
Results
A total of 63 patients were admitted to the HO service between December 2020 through February 2021. Of those, 53 (84.1%) met at least 1 trigger and 36 (68%) received PC consultation. Of the patients that met trigger criteria and received a PC consult, 85.7% died with hospice compared to 44.4% in the group who did not receive a PC consult (P < .01). Nineteen (51.3%) died within 6 months of discharge compared to 7 (26.9%) who did not receive a PC consult (P = .08). Twelve (33.3%) had recurrent hospitalizations compared to 5 (29%) who did not receive a PC consult (P = .38), and 20 (55.6%) had a new or updated LST note compared to 2 (11.8%) who did not receive PC consultation (P < .01).
Conculsions
This study demonstrated the feasibility of implementing a trigger-based system for PC consultation in a veteran inpatient HO population. Notably, a large majority of HO inpatients met criteria for at least 1 PC trigger. No significant difference was found in overall survival at 6 months; however, patients who received PC consultation were more likely to receive hospice services at the end of life.
Purpose
Hospitalized patients with advanced malignancies often have high symptom burden and poor quality of life, which are frequently under-recognized or under-treated. Accordingly, the integration of specialty palliative care (PC) in this population is imperative. Unfortunately, a sustainable referral model to capture patients for timely PC involvement is lacking. This quality improvement study evaluated the implementation of a clinical trigger-based referral process to PC for inpatients on the Hematology/Oncology (HO) service at Hines VA Hospital. Clinical outcomes studied included: Life-Sustaining Treatment (LST) note completion rates; measurement of overall survival at 3, 6, and 12 months; rate of re-hospitalization within 30 days; and venue of death and treating specialty of deceased patients.
Methods
House staff received a weekly email that included the clinical PC triggers. Admitted patients who met trigger criteria would prompt consultation to PC. Clinical triggers included: metastatic oncologic disease or relapsed hematologic disease; uncontrolled symptoms; > 2 unscheduled hospitalizations in the prior 30 days; and unscheduled hospitalizations lasting > 7 days.
Results
A total of 63 patients were admitted to the HO service between December 2020 through February 2021. Of those, 53 (84.1%) met at least 1 trigger and 36 (68%) received PC consultation. Of the patients that met trigger criteria and received a PC consult, 85.7% died with hospice compared to 44.4% in the group who did not receive a PC consult (P < .01). Nineteen (51.3%) died within 6 months of discharge compared to 7 (26.9%) who did not receive a PC consult (P = .08). Twelve (33.3%) had recurrent hospitalizations compared to 5 (29%) who did not receive a PC consult (P = .38), and 20 (55.6%) had a new or updated LST note compared to 2 (11.8%) who did not receive PC consultation (P < .01).
Conculsions
This study demonstrated the feasibility of implementing a trigger-based system for PC consultation in a veteran inpatient HO population. Notably, a large majority of HO inpatients met criteria for at least 1 PC trigger. No significant difference was found in overall survival at 6 months; however, patients who received PC consultation were more likely to receive hospice services at the end of life.
Purpose
Hospitalized patients with advanced malignancies often have high symptom burden and poor quality of life, which are frequently under-recognized or under-treated. Accordingly, the integration of specialty palliative care (PC) in this population is imperative. Unfortunately, a sustainable referral model to capture patients for timely PC involvement is lacking. This quality improvement study evaluated the implementation of a clinical trigger-based referral process to PC for inpatients on the Hematology/Oncology (HO) service at Hines VA Hospital. Clinical outcomes studied included: Life-Sustaining Treatment (LST) note completion rates; measurement of overall survival at 3, 6, and 12 months; rate of re-hospitalization within 30 days; and venue of death and treating specialty of deceased patients.
Methods
House staff received a weekly email that included the clinical PC triggers. Admitted patients who met trigger criteria would prompt consultation to PC. Clinical triggers included: metastatic oncologic disease or relapsed hematologic disease; uncontrolled symptoms; > 2 unscheduled hospitalizations in the prior 30 days; and unscheduled hospitalizations lasting > 7 days.
Results
A total of 63 patients were admitted to the HO service between December 2020 through February 2021. Of those, 53 (84.1%) met at least 1 trigger and 36 (68%) received PC consultation. Of the patients that met trigger criteria and received a PC consult, 85.7% died with hospice compared to 44.4% in the group who did not receive a PC consult (P < .01). Nineteen (51.3%) died within 6 months of discharge compared to 7 (26.9%) who did not receive a PC consult (P = .08). Twelve (33.3%) had recurrent hospitalizations compared to 5 (29%) who did not receive a PC consult (P = .38), and 20 (55.6%) had a new or updated LST note compared to 2 (11.8%) who did not receive PC consultation (P < .01).
Conculsions
This study demonstrated the feasibility of implementing a trigger-based system for PC consultation in a veteran inpatient HO population. Notably, a large majority of HO inpatients met criteria for at least 1 PC trigger. No significant difference was found in overall survival at 6 months; however, patients who received PC consultation were more likely to receive hospice services at the end of life.
Hepatitis B Virus (HBV) Testing in Veterans Receiving Systemic Anticancer Treatment
Purpose
Examine hepatitis B virus (HBV) testing in veterans receiving systemic anticancer treatment (SACT) in the Veterans Health Administration (VHA).
Background
HBV reactivation is reported in patients with chronic (HB surface antigen, HBsAg, positive) or prior (HB core antibody, HBcAb, positive) HBV infection, who receive SACT. A recent American Society of Clinical Oncology provisional clinical opinion update recommended HBV screening for all patients prior to initiation of SACT (excluding hormonal therapy). HBV testing and the incidence of hepatitis in veterans receiving SACT in the VHA has not been reported.
Methods/Data Analysis
VHA EHR data were used to identify veterans receiving SACT (01/2010-12/2021). Testing for HBsAg, HBcAb and alanine aminotransferase (ALT) was extracted. Patients known to have HBV or elevated ALT prior to first SACT, and those receiving anti-CD20 were excluded. Patients were followed until two years after the last SACT or 12/2021, whichever occurred first. Patients receiving intravenous SACT and those receiving oral SACT are described separately.
Results
Between 2010 and 2021, 215,395 veterans received an intravenous SACT, while 80,752 veterans received an oral SACT. Of patients treated with an SACT, 80% had no evidence of HBsAg or HBcAb testing prior to treatment initiation, and 8-12% experienced at least one elevated ALT between treatment initiation and two years after the last SACT. There was no evidence of increased ALT elevation in patients who were not tested compared to those that were tested prior to treatment initiation. In patients with at least one ALT elevation, approximately 30% were tested for HBV and of these, 3% tested positive.
Conclusions/Implications
Most veterans receiving SACT are not tested for HBV prior to treatment initiation, and do not experience elevated ALTs. In patients with elevated ALT during or subsequent to SACT, the majority are not tested for HBV. Veterans that are tested reveal an HBV prevalence of about 10%. Our results suggest that HBV testing prior to SACT initiation should not be at the expense of delaying treatment, given the magnitude of proposed change from current practice and the anticipated low probability of benefit.
Purpose
Examine hepatitis B virus (HBV) testing in veterans receiving systemic anticancer treatment (SACT) in the Veterans Health Administration (VHA).
Background
HBV reactivation is reported in patients with chronic (HB surface antigen, HBsAg, positive) or prior (HB core antibody, HBcAb, positive) HBV infection, who receive SACT. A recent American Society of Clinical Oncology provisional clinical opinion update recommended HBV screening for all patients prior to initiation of SACT (excluding hormonal therapy). HBV testing and the incidence of hepatitis in veterans receiving SACT in the VHA has not been reported.
Methods/Data Analysis
VHA EHR data were used to identify veterans receiving SACT (01/2010-12/2021). Testing for HBsAg, HBcAb and alanine aminotransferase (ALT) was extracted. Patients known to have HBV or elevated ALT prior to first SACT, and those receiving anti-CD20 were excluded. Patients were followed until two years after the last SACT or 12/2021, whichever occurred first. Patients receiving intravenous SACT and those receiving oral SACT are described separately.
Results
Between 2010 and 2021, 215,395 veterans received an intravenous SACT, while 80,752 veterans received an oral SACT. Of patients treated with an SACT, 80% had no evidence of HBsAg or HBcAb testing prior to treatment initiation, and 8-12% experienced at least one elevated ALT between treatment initiation and two years after the last SACT. There was no evidence of increased ALT elevation in patients who were not tested compared to those that were tested prior to treatment initiation. In patients with at least one ALT elevation, approximately 30% were tested for HBV and of these, 3% tested positive.
Conclusions/Implications
Most veterans receiving SACT are not tested for HBV prior to treatment initiation, and do not experience elevated ALTs. In patients with elevated ALT during or subsequent to SACT, the majority are not tested for HBV. Veterans that are tested reveal an HBV prevalence of about 10%. Our results suggest that HBV testing prior to SACT initiation should not be at the expense of delaying treatment, given the magnitude of proposed change from current practice and the anticipated low probability of benefit.
Purpose
Examine hepatitis B virus (HBV) testing in veterans receiving systemic anticancer treatment (SACT) in the Veterans Health Administration (VHA).
Background
HBV reactivation is reported in patients with chronic (HB surface antigen, HBsAg, positive) or prior (HB core antibody, HBcAb, positive) HBV infection, who receive SACT. A recent American Society of Clinical Oncology provisional clinical opinion update recommended HBV screening for all patients prior to initiation of SACT (excluding hormonal therapy). HBV testing and the incidence of hepatitis in veterans receiving SACT in the VHA has not been reported.
Methods/Data Analysis
VHA EHR data were used to identify veterans receiving SACT (01/2010-12/2021). Testing for HBsAg, HBcAb and alanine aminotransferase (ALT) was extracted. Patients known to have HBV or elevated ALT prior to first SACT, and those receiving anti-CD20 were excluded. Patients were followed until two years after the last SACT or 12/2021, whichever occurred first. Patients receiving intravenous SACT and those receiving oral SACT are described separately.
Results
Between 2010 and 2021, 215,395 veterans received an intravenous SACT, while 80,752 veterans received an oral SACT. Of patients treated with an SACT, 80% had no evidence of HBsAg or HBcAb testing prior to treatment initiation, and 8-12% experienced at least one elevated ALT between treatment initiation and two years after the last SACT. There was no evidence of increased ALT elevation in patients who were not tested compared to those that were tested prior to treatment initiation. In patients with at least one ALT elevation, approximately 30% were tested for HBV and of these, 3% tested positive.
Conclusions/Implications
Most veterans receiving SACT are not tested for HBV prior to treatment initiation, and do not experience elevated ALTs. In patients with elevated ALT during or subsequent to SACT, the majority are not tested for HBV. Veterans that are tested reveal an HBV prevalence of about 10%. Our results suggest that HBV testing prior to SACT initiation should not be at the expense of delaying treatment, given the magnitude of proposed change from current practice and the anticipated low probability of benefit.
The Effect of Adjuvant Therapy Type on Survival for Patients With Sage II Osteosarcoma
Background
Osteosarcoma is an aggressive bone malignancy often treated with surgery. On diagnosis, the majority of patients present with stage II disease. The objective of this study was to compare differences in survival between three commonly used adjuvant therapies: chemotherapy, radiation, and combined chemoradiation therapy in patients presenting with stage II disease.
Methods
The National Cancer Database (NCDB) was used to identify patients diagnosed with osteosarcoma from 2004 to 2018 using the ICD-O-3 histology codes 9180-9187. Patients with stage II disease and who had undergone a surgical procedure at the primary site were identified. Patients were grouped by the receipt of adjuvant chemotherapy, radiation, or chemoradiation. Descriptive statistics and Kaplan-Meier curves were used to measure survival in these patients. One way ANOVA and chi-square analyses were used to evaluate differences among treatment groups. Data were analyzed using SPSS and statistical significance was set at P = .05.
Results
Of 9955 patients in the NCDB diagnosed with osteosarcoma, 4378 (44%) presented with stage II disease. 710 (17.9%) of these surgical patients received additional adjuvant therapy. 66.0% received chemotherapy, 24.4% received radiation, and 9.57% received combined chemoradiation. Adjuvant chemotherapy had the longest median survival time of 91.7 months. Median survival for adjuvant radiotherapy was 48 months and combined chemoradiation was 50.5 months. On log-rank pairwise comparison, the difference in survival between adjuvant chemotherapy and adjuvant chemoradiation was found to be statistically significant. (P < .001). Patients receiving adjuvant chemotherapy were more likely to be younger and have private insurance. (P < .05) Conversely, patients receiving adjuvant radiation were more likely to be older and have Medicare. (P < .05). No significant differences were seen among patient race, sex, income, or Charleson-Deyo comorbidity score.
Conclusions
This study showed that patients with stage II osteosarcoma who receive adjuvant chemotherapy experience improved median survival in comparison to patients who receive adjuvant radiation. This is an important clinical finding, which should guide future treatment. However, further investigation is required to identify patient and treatment specific factors, which are contributing to mortality.
Background
Osteosarcoma is an aggressive bone malignancy often treated with surgery. On diagnosis, the majority of patients present with stage II disease. The objective of this study was to compare differences in survival between three commonly used adjuvant therapies: chemotherapy, radiation, and combined chemoradiation therapy in patients presenting with stage II disease.
Methods
The National Cancer Database (NCDB) was used to identify patients diagnosed with osteosarcoma from 2004 to 2018 using the ICD-O-3 histology codes 9180-9187. Patients with stage II disease and who had undergone a surgical procedure at the primary site were identified. Patients were grouped by the receipt of adjuvant chemotherapy, radiation, or chemoradiation. Descriptive statistics and Kaplan-Meier curves were used to measure survival in these patients. One way ANOVA and chi-square analyses were used to evaluate differences among treatment groups. Data were analyzed using SPSS and statistical significance was set at P = .05.
Results
Of 9955 patients in the NCDB diagnosed with osteosarcoma, 4378 (44%) presented with stage II disease. 710 (17.9%) of these surgical patients received additional adjuvant therapy. 66.0% received chemotherapy, 24.4% received radiation, and 9.57% received combined chemoradiation. Adjuvant chemotherapy had the longest median survival time of 91.7 months. Median survival for adjuvant radiotherapy was 48 months and combined chemoradiation was 50.5 months. On log-rank pairwise comparison, the difference in survival between adjuvant chemotherapy and adjuvant chemoradiation was found to be statistically significant. (P < .001). Patients receiving adjuvant chemotherapy were more likely to be younger and have private insurance. (P < .05) Conversely, patients receiving adjuvant radiation were more likely to be older and have Medicare. (P < .05). No significant differences were seen among patient race, sex, income, or Charleson-Deyo comorbidity score.
Conclusions
This study showed that patients with stage II osteosarcoma who receive adjuvant chemotherapy experience improved median survival in comparison to patients who receive adjuvant radiation. This is an important clinical finding, which should guide future treatment. However, further investigation is required to identify patient and treatment specific factors, which are contributing to mortality.
Background
Osteosarcoma is an aggressive bone malignancy often treated with surgery. On diagnosis, the majority of patients present with stage II disease. The objective of this study was to compare differences in survival between three commonly used adjuvant therapies: chemotherapy, radiation, and combined chemoradiation therapy in patients presenting with stage II disease.
Methods
The National Cancer Database (NCDB) was used to identify patients diagnosed with osteosarcoma from 2004 to 2018 using the ICD-O-3 histology codes 9180-9187. Patients with stage II disease and who had undergone a surgical procedure at the primary site were identified. Patients were grouped by the receipt of adjuvant chemotherapy, radiation, or chemoradiation. Descriptive statistics and Kaplan-Meier curves were used to measure survival in these patients. One way ANOVA and chi-square analyses were used to evaluate differences among treatment groups. Data were analyzed using SPSS and statistical significance was set at P = .05.
Results
Of 9955 patients in the NCDB diagnosed with osteosarcoma, 4378 (44%) presented with stage II disease. 710 (17.9%) of these surgical patients received additional adjuvant therapy. 66.0% received chemotherapy, 24.4% received radiation, and 9.57% received combined chemoradiation. Adjuvant chemotherapy had the longest median survival time of 91.7 months. Median survival for adjuvant radiotherapy was 48 months and combined chemoradiation was 50.5 months. On log-rank pairwise comparison, the difference in survival between adjuvant chemotherapy and adjuvant chemoradiation was found to be statistically significant. (P < .001). Patients receiving adjuvant chemotherapy were more likely to be younger and have private insurance. (P < .05) Conversely, patients receiving adjuvant radiation were more likely to be older and have Medicare. (P < .05). No significant differences were seen among patient race, sex, income, or Charleson-Deyo comorbidity score.
Conclusions
This study showed that patients with stage II osteosarcoma who receive adjuvant chemotherapy experience improved median survival in comparison to patients who receive adjuvant radiation. This is an important clinical finding, which should guide future treatment. However, further investigation is required to identify patient and treatment specific factors, which are contributing to mortality.
Utilization and Clinical Benefit of Immune Checkpoint Inhibitor in Veterans With Microsatellite Instability-High Prostate Cancer
Background
The utilization of immune checkpoint inhibitors (ICI) in prostate cancer (PC) can be very effective for patients with mismatch repair-deficiency (as identified by MSI-H by PCR/NGS or dMMR IHC). The use of ICI in this patient population has been associated with high rates of durable response. There is limited published data on factors that may influence patient response and outcomes. The aim of this study is to describe the utilization of and tumor response to ICI in this patient population.
Methods
This is a retrospective study of men with MSI-H PC reported by somatic genomic testing from April 1, 2015 to March 31, 2022 through the VA National Precision Oncology Program (NPOP), who received at least one dose of ICI. The primary objectives are to describe the incidence of MSI-H PC and the utilization of ICI. Descriptive statistics and Kaplan- Meier estimator were used for secondary objectives to determine the prostate-specific antigen decline of at least 50% (PSA50), clinical progression free survival (cPFS), time on ICI as a function of number of prior therapies, the extent of metastasis prior to initiation of ICI, and the correlation of MMR genetic alterations with treatment response.
Results
66 patients with MSI-H PC were identified (1.5% of a total of 4267 patients with PC tested through NPOP). 23 patients (35%) received at least one dose of ICI. 12 of 23 patients (52%) had PSA response. PSA50 responses occurred in 6 patients (50%) and 5 continued to have durable PSA50 at six months. Median cPFS was 280 days (95% CI: 105 days-not reached) and the estimated PFS at six months was 72.2% (95% CI: 35.7%-90.2%). 8 of 12 (67%) responders have received multiple lines of therapy for M1 PC. 8 of 12 patients (67%) had high-volume disease at ICI initiation. Of those patients with a MMR genetic alteration, patients with MLH1 (3/3) and MSH2 (6/8) alterations responded more frequently than those with MSH6 alterations (1/4).
Conclusions
MSI-H PC is rare but response rates to ICI are high and durable. Patients with MLH1 and MSH2 alterations appeared to respond more frequently than those with MSH6. Additional follow-up is ongoing.
Background
The utilization of immune checkpoint inhibitors (ICI) in prostate cancer (PC) can be very effective for patients with mismatch repair-deficiency (as identified by MSI-H by PCR/NGS or dMMR IHC). The use of ICI in this patient population has been associated with high rates of durable response. There is limited published data on factors that may influence patient response and outcomes. The aim of this study is to describe the utilization of and tumor response to ICI in this patient population.
Methods
This is a retrospective study of men with MSI-H PC reported by somatic genomic testing from April 1, 2015 to March 31, 2022 through the VA National Precision Oncology Program (NPOP), who received at least one dose of ICI. The primary objectives are to describe the incidence of MSI-H PC and the utilization of ICI. Descriptive statistics and Kaplan- Meier estimator were used for secondary objectives to determine the prostate-specific antigen decline of at least 50% (PSA50), clinical progression free survival (cPFS), time on ICI as a function of number of prior therapies, the extent of metastasis prior to initiation of ICI, and the correlation of MMR genetic alterations with treatment response.
Results
66 patients with MSI-H PC were identified (1.5% of a total of 4267 patients with PC tested through NPOP). 23 patients (35%) received at least one dose of ICI. 12 of 23 patients (52%) had PSA response. PSA50 responses occurred in 6 patients (50%) and 5 continued to have durable PSA50 at six months. Median cPFS was 280 days (95% CI: 105 days-not reached) and the estimated PFS at six months was 72.2% (95% CI: 35.7%-90.2%). 8 of 12 (67%) responders have received multiple lines of therapy for M1 PC. 8 of 12 patients (67%) had high-volume disease at ICI initiation. Of those patients with a MMR genetic alteration, patients with MLH1 (3/3) and MSH2 (6/8) alterations responded more frequently than those with MSH6 alterations (1/4).
Conclusions
MSI-H PC is rare but response rates to ICI are high and durable. Patients with MLH1 and MSH2 alterations appeared to respond more frequently than those with MSH6. Additional follow-up is ongoing.
Background
The utilization of immune checkpoint inhibitors (ICI) in prostate cancer (PC) can be very effective for patients with mismatch repair-deficiency (as identified by MSI-H by PCR/NGS or dMMR IHC). The use of ICI in this patient population has been associated with high rates of durable response. There is limited published data on factors that may influence patient response and outcomes. The aim of this study is to describe the utilization of and tumor response to ICI in this patient population.
Methods
This is a retrospective study of men with MSI-H PC reported by somatic genomic testing from April 1, 2015 to March 31, 2022 through the VA National Precision Oncology Program (NPOP), who received at least one dose of ICI. The primary objectives are to describe the incidence of MSI-H PC and the utilization of ICI. Descriptive statistics and Kaplan- Meier estimator were used for secondary objectives to determine the prostate-specific antigen decline of at least 50% (PSA50), clinical progression free survival (cPFS), time on ICI as a function of number of prior therapies, the extent of metastasis prior to initiation of ICI, and the correlation of MMR genetic alterations with treatment response.
Results
66 patients with MSI-H PC were identified (1.5% of a total of 4267 patients with PC tested through NPOP). 23 patients (35%) received at least one dose of ICI. 12 of 23 patients (52%) had PSA response. PSA50 responses occurred in 6 patients (50%) and 5 continued to have durable PSA50 at six months. Median cPFS was 280 days (95% CI: 105 days-not reached) and the estimated PFS at six months was 72.2% (95% CI: 35.7%-90.2%). 8 of 12 (67%) responders have received multiple lines of therapy for M1 PC. 8 of 12 patients (67%) had high-volume disease at ICI initiation. Of those patients with a MMR genetic alteration, patients with MLH1 (3/3) and MSH2 (6/8) alterations responded more frequently than those with MSH6 alterations (1/4).
Conclusions
MSI-H PC is rare but response rates to ICI are high and durable. Patients with MLH1 and MSH2 alterations appeared to respond more frequently than those with MSH6. Additional follow-up is ongoing.
From B to T: a Case of Concurrent B-Cell and T-Cell Lymphomas Successfully Palliated With Targeted Therapies
Background
Diffuse large B-cell lymphoma (DLBCL) is the most common aggressive type of non- Hodgkin lymphoma (NHL), comprising 30% of all NHL. Due to a decreased state of immunosurveillance resulting from the disease itself and its associated therapies, patients are at increased risk of developing a secondary malignancy. Multiple primary malignancies have been reported to occur in up to 15% of patients with DLBCL, retrospectively.
Herein, we review a case of a man with DLBCL who concomitantly developed ALK negative anaplastic large cell lymphoma (ALCL) distinctly of T-cell lineage who was successfully treated with palliative therapy for both diagnoses despite his advanced age and diagnosis associated with a poor prognosis with continued effect and sustained quality of life.
Case Report
An 88-year-old man presented with stage III DLBCL, diagnosed in 12/2018, was deemed not to be an aggressive therapy candidate. As such, he was treated with Rituximab monotherapy for 6 cycles, ending in 02/2019, with remarkably good effect. He remained in a PR with stable disease on serial PET/CTs until 09/2021, at which time he was noted to have Horner’s Syndrome in clinic. CT chest demonstrated a right apical lung mass, not previously seen on prior scans measuring 4.2 x 2.7 cm. Other sites of nodal disease remained stable on PET/CT.
Biopsy of the lesion revealed CD30+ ALK-negative ALCL with distinct T-cell marker positivity on immunohistochemistry and the absence of B-cell lineage markers. After discussion at our treatment planning conference, we decided to treat with brentuximab-vedotin (Bv) monotherapy for 6 cycles. End of treatment PET/CT demonstrated a PR with near resolution in background PET avidity at the lesion. His symptoms of Horner syndrome also improved.
Conclusion
A diagnosis of aggressive lymphoma increases the risk of developing a secondary malignancy and providers should remain vigilant of this. Elderly individuals in whom aggressive therapies may be precluded can still greatly benefit from palliative targeted therapy even in the setting of diseases historically associated with a poor prognosis.
Background
Diffuse large B-cell lymphoma (DLBCL) is the most common aggressive type of non- Hodgkin lymphoma (NHL), comprising 30% of all NHL. Due to a decreased state of immunosurveillance resulting from the disease itself and its associated therapies, patients are at increased risk of developing a secondary malignancy. Multiple primary malignancies have been reported to occur in up to 15% of patients with DLBCL, retrospectively.
Herein, we review a case of a man with DLBCL who concomitantly developed ALK negative anaplastic large cell lymphoma (ALCL) distinctly of T-cell lineage who was successfully treated with palliative therapy for both diagnoses despite his advanced age and diagnosis associated with a poor prognosis with continued effect and sustained quality of life.
Case Report
An 88-year-old man presented with stage III DLBCL, diagnosed in 12/2018, was deemed not to be an aggressive therapy candidate. As such, he was treated with Rituximab monotherapy for 6 cycles, ending in 02/2019, with remarkably good effect. He remained in a PR with stable disease on serial PET/CTs until 09/2021, at which time he was noted to have Horner’s Syndrome in clinic. CT chest demonstrated a right apical lung mass, not previously seen on prior scans measuring 4.2 x 2.7 cm. Other sites of nodal disease remained stable on PET/CT.
Biopsy of the lesion revealed CD30+ ALK-negative ALCL with distinct T-cell marker positivity on immunohistochemistry and the absence of B-cell lineage markers. After discussion at our treatment planning conference, we decided to treat with brentuximab-vedotin (Bv) monotherapy for 6 cycles. End of treatment PET/CT demonstrated a PR with near resolution in background PET avidity at the lesion. His symptoms of Horner syndrome also improved.
Conclusion
A diagnosis of aggressive lymphoma increases the risk of developing a secondary malignancy and providers should remain vigilant of this. Elderly individuals in whom aggressive therapies may be precluded can still greatly benefit from palliative targeted therapy even in the setting of diseases historically associated with a poor prognosis.
Background
Diffuse large B-cell lymphoma (DLBCL) is the most common aggressive type of non- Hodgkin lymphoma (NHL), comprising 30% of all NHL. Due to a decreased state of immunosurveillance resulting from the disease itself and its associated therapies, patients are at increased risk of developing a secondary malignancy. Multiple primary malignancies have been reported to occur in up to 15% of patients with DLBCL, retrospectively.
Herein, we review a case of a man with DLBCL who concomitantly developed ALK negative anaplastic large cell lymphoma (ALCL) distinctly of T-cell lineage who was successfully treated with palliative therapy for both diagnoses despite his advanced age and diagnosis associated with a poor prognosis with continued effect and sustained quality of life.
Case Report
An 88-year-old man presented with stage III DLBCL, diagnosed in 12/2018, was deemed not to be an aggressive therapy candidate. As such, he was treated with Rituximab monotherapy for 6 cycles, ending in 02/2019, with remarkably good effect. He remained in a PR with stable disease on serial PET/CTs until 09/2021, at which time he was noted to have Horner’s Syndrome in clinic. CT chest demonstrated a right apical lung mass, not previously seen on prior scans measuring 4.2 x 2.7 cm. Other sites of nodal disease remained stable on PET/CT.
Biopsy of the lesion revealed CD30+ ALK-negative ALCL with distinct T-cell marker positivity on immunohistochemistry and the absence of B-cell lineage markers. After discussion at our treatment planning conference, we decided to treat with brentuximab-vedotin (Bv) monotherapy for 6 cycles. End of treatment PET/CT demonstrated a PR with near resolution in background PET avidity at the lesion. His symptoms of Horner syndrome also improved.
Conclusion
A diagnosis of aggressive lymphoma increases the risk of developing a secondary malignancy and providers should remain vigilant of this. Elderly individuals in whom aggressive therapies may be precluded can still greatly benefit from palliative targeted therapy even in the setting of diseases historically associated with a poor prognosis.
Concurrent Romiplostim With FOLFIRINOX for Secondary Prevention of Thrombocytopenia in a Patient With Myelodysplastic Syndrome and Pancreatic Adenocarcinoma
Inroduction
Romiplostim is an agonist of the thrombopoietin receptor that stimulates platelet production. Several studies have evaluated the role of romiplostim in the prevention of chemotherapy-induced thrombocytopenia (CIT). Romiplostim may reduce dose reductions, treatment delays, bleeding events, and transfusions.
Less is known about treatment of CIT in patients with pre-existing thrombocytopenia (TCP), such as those with myelodysplastic syndrome (MDS). Here we present a case of a patient with TCP secondary to MDS who was given romiplostim during the treatment of pancreatic adenocarcinoma with FOLFIRINOX.
Case Report
The patient is a 76-year-old male with history of chronic TCP (baseline platelets 50-90 K/μL) presumed secondary to myelodysplastic syndrome, although a bone marrow biopsy was inconclusive. He had not had any major bleeding events or transfusions, aside from one unit of platelets given after a cervical spine fusion.
He was later diagnosed with borderline-resectable pancreatic adenocarcinoma, Stage IbT2N0. Plan made to administer neoadjuvant FOLFIRNOX chemotherapy, followed by Whipple.
The patient was started on romiplostim with a dose range of 1-10 mcg/kg weekly to maintain platelets between 60-200. We initially planned to give all 12 cycles neoadjuvantly but found that we could not maintain a platelet count over 50 K/μL despite maximal uptitration of romiplostim so the Whipple was performed after Cycle 9. Three additional cycles were given post-operatively. There were no dose-reductions, although oxaliplatin was held after cycle 9 due to neuropathy. He developed a jejunal bleed post-Whipple that required embolization but did not require transfusion.
Summary
This was a case in which romiplostim was successfully used during FOLFIRINOX to support platelets in a patient with baseline TCP from MDS. Despite a jejunal bleed after Whipple, the patient tolerated the treatment well and was able to complete all 12 cycles of peri-operative FOLFIRINOX. This approach may be beneficial in other patients with pre-existing TCP receiving chemotherapy.
Inroduction
Romiplostim is an agonist of the thrombopoietin receptor that stimulates platelet production. Several studies have evaluated the role of romiplostim in the prevention of chemotherapy-induced thrombocytopenia (CIT). Romiplostim may reduce dose reductions, treatment delays, bleeding events, and transfusions.
Less is known about treatment of CIT in patients with pre-existing thrombocytopenia (TCP), such as those with myelodysplastic syndrome (MDS). Here we present a case of a patient with TCP secondary to MDS who was given romiplostim during the treatment of pancreatic adenocarcinoma with FOLFIRINOX.
Case Report
The patient is a 76-year-old male with history of chronic TCP (baseline platelets 50-90 K/μL) presumed secondary to myelodysplastic syndrome, although a bone marrow biopsy was inconclusive. He had not had any major bleeding events or transfusions, aside from one unit of platelets given after a cervical spine fusion.
He was later diagnosed with borderline-resectable pancreatic adenocarcinoma, Stage IbT2N0. Plan made to administer neoadjuvant FOLFIRNOX chemotherapy, followed by Whipple.
The patient was started on romiplostim with a dose range of 1-10 mcg/kg weekly to maintain platelets between 60-200. We initially planned to give all 12 cycles neoadjuvantly but found that we could not maintain a platelet count over 50 K/μL despite maximal uptitration of romiplostim so the Whipple was performed after Cycle 9. Three additional cycles were given post-operatively. There were no dose-reductions, although oxaliplatin was held after cycle 9 due to neuropathy. He developed a jejunal bleed post-Whipple that required embolization but did not require transfusion.
Summary
This was a case in which romiplostim was successfully used during FOLFIRINOX to support platelets in a patient with baseline TCP from MDS. Despite a jejunal bleed after Whipple, the patient tolerated the treatment well and was able to complete all 12 cycles of peri-operative FOLFIRINOX. This approach may be beneficial in other patients with pre-existing TCP receiving chemotherapy.
Inroduction
Romiplostim is an agonist of the thrombopoietin receptor that stimulates platelet production. Several studies have evaluated the role of romiplostim in the prevention of chemotherapy-induced thrombocytopenia (CIT). Romiplostim may reduce dose reductions, treatment delays, bleeding events, and transfusions.
Less is known about treatment of CIT in patients with pre-existing thrombocytopenia (TCP), such as those with myelodysplastic syndrome (MDS). Here we present a case of a patient with TCP secondary to MDS who was given romiplostim during the treatment of pancreatic adenocarcinoma with FOLFIRINOX.
Case Report
The patient is a 76-year-old male with history of chronic TCP (baseline platelets 50-90 K/μL) presumed secondary to myelodysplastic syndrome, although a bone marrow biopsy was inconclusive. He had not had any major bleeding events or transfusions, aside from one unit of platelets given after a cervical spine fusion.
He was later diagnosed with borderline-resectable pancreatic adenocarcinoma, Stage IbT2N0. Plan made to administer neoadjuvant FOLFIRNOX chemotherapy, followed by Whipple.
The patient was started on romiplostim with a dose range of 1-10 mcg/kg weekly to maintain platelets between 60-200. We initially planned to give all 12 cycles neoadjuvantly but found that we could not maintain a platelet count over 50 K/μL despite maximal uptitration of romiplostim so the Whipple was performed after Cycle 9. Three additional cycles were given post-operatively. There were no dose-reductions, although oxaliplatin was held after cycle 9 due to neuropathy. He developed a jejunal bleed post-Whipple that required embolization but did not require transfusion.
Summary
This was a case in which romiplostim was successfully used during FOLFIRINOX to support platelets in a patient with baseline TCP from MDS. Despite a jejunal bleed after Whipple, the patient tolerated the treatment well and was able to complete all 12 cycles of peri-operative FOLFIRINOX. This approach may be beneficial in other patients with pre-existing TCP receiving chemotherapy.
A Case Report of Palliative Pembrolizumab Monotherapy for a Poorly Differentiated Malignancy
Introduction
The critical role of palliative radiotherapy (RT) in the management of advanced cancer is evolving due to the advent of novel therapeuticapproaches. We report the case of a veteran with a soft tissue metastasis who had a robust response to pembrolizumab, allowing for the deferral of palliative RT.
Case Presentation
An 86-year-old male presented with a rapidly growing, painful, malodorous, fungating right inguinal soft tissue mass measuring 10×7×3 cm that had rendered the patient non-ambulatory, with subsequent imaging also demonstrating a left pleural-based lung mass. Biopsy was consistent with a poorly differentiated carcinoma, and molecular profiling revealed a KRAS G12C mutation, high tumor mutational burden (TMB 18 mutations/megabase), and high PD-L1 expression (TPS 100%). The patient’s poor functional status precluded the use of aggressive combination chemotherapy, but the molecular features were favorable for response to immune checkpoint inhibitor monotherapy, which is better tolerated. He was initiated on pembrolizumab with the goal of symptom palliation and potentially prolonging his life. However, as rapid responses to immunotherapy are uncommon, radiation oncology was consulted for palliative RT. Twenty days after starting pembrolizumab and 2 weeks after RT simulation, the inguinal mass had markedly regressed with an open tissue defect at the site. As the palliative goal had been achieved, RT was deferred to avoid the development of a non-healing wound.
Conclusions
Our case highlights palliative treatment modalities for soft tissue masses. Immunotherapy is now a component of first-line therapy in many cancer types, but rapid and robust responses to monotherapy are rare. There is the exciting potential to combine immunotherapy with RT, with small case series indicating synergy, although further research is needed. In cases with molecular characteristics favoring response to immunotherapy, an optimal sequencing approach may incorporate an initial run-in phase with immunotherapy to determine if symptom palliation can be achieved with unimodal therapy. The location of the mass in a non-radiation sensitive region allowed us to entertain the use of combination therapy for our patient, but ultimately was not needed. Palliative RT will remain an option at the time of cancer progression.
Introduction
The critical role of palliative radiotherapy (RT) in the management of advanced cancer is evolving due to the advent of novel therapeuticapproaches. We report the case of a veteran with a soft tissue metastasis who had a robust response to pembrolizumab, allowing for the deferral of palliative RT.
Case Presentation
An 86-year-old male presented with a rapidly growing, painful, malodorous, fungating right inguinal soft tissue mass measuring 10×7×3 cm that had rendered the patient non-ambulatory, with subsequent imaging also demonstrating a left pleural-based lung mass. Biopsy was consistent with a poorly differentiated carcinoma, and molecular profiling revealed a KRAS G12C mutation, high tumor mutational burden (TMB 18 mutations/megabase), and high PD-L1 expression (TPS 100%). The patient’s poor functional status precluded the use of aggressive combination chemotherapy, but the molecular features were favorable for response to immune checkpoint inhibitor monotherapy, which is better tolerated. He was initiated on pembrolizumab with the goal of symptom palliation and potentially prolonging his life. However, as rapid responses to immunotherapy are uncommon, radiation oncology was consulted for palliative RT. Twenty days after starting pembrolizumab and 2 weeks after RT simulation, the inguinal mass had markedly regressed with an open tissue defect at the site. As the palliative goal had been achieved, RT was deferred to avoid the development of a non-healing wound.
Conclusions
Our case highlights palliative treatment modalities for soft tissue masses. Immunotherapy is now a component of first-line therapy in many cancer types, but rapid and robust responses to monotherapy are rare. There is the exciting potential to combine immunotherapy with RT, with small case series indicating synergy, although further research is needed. In cases with molecular characteristics favoring response to immunotherapy, an optimal sequencing approach may incorporate an initial run-in phase with immunotherapy to determine if symptom palliation can be achieved with unimodal therapy. The location of the mass in a non-radiation sensitive region allowed us to entertain the use of combination therapy for our patient, but ultimately was not needed. Palliative RT will remain an option at the time of cancer progression.
Introduction
The critical role of palliative radiotherapy (RT) in the management of advanced cancer is evolving due to the advent of novel therapeuticapproaches. We report the case of a veteran with a soft tissue metastasis who had a robust response to pembrolizumab, allowing for the deferral of palliative RT.
Case Presentation
An 86-year-old male presented with a rapidly growing, painful, malodorous, fungating right inguinal soft tissue mass measuring 10×7×3 cm that had rendered the patient non-ambulatory, with subsequent imaging also demonstrating a left pleural-based lung mass. Biopsy was consistent with a poorly differentiated carcinoma, and molecular profiling revealed a KRAS G12C mutation, high tumor mutational burden (TMB 18 mutations/megabase), and high PD-L1 expression (TPS 100%). The patient’s poor functional status precluded the use of aggressive combination chemotherapy, but the molecular features were favorable for response to immune checkpoint inhibitor monotherapy, which is better tolerated. He was initiated on pembrolizumab with the goal of symptom palliation and potentially prolonging his life. However, as rapid responses to immunotherapy are uncommon, radiation oncology was consulted for palliative RT. Twenty days after starting pembrolizumab and 2 weeks after RT simulation, the inguinal mass had markedly regressed with an open tissue defect at the site. As the palliative goal had been achieved, RT was deferred to avoid the development of a non-healing wound.
Conclusions
Our case highlights palliative treatment modalities for soft tissue masses. Immunotherapy is now a component of first-line therapy in many cancer types, but rapid and robust responses to monotherapy are rare. There is the exciting potential to combine immunotherapy with RT, with small case series indicating synergy, although further research is needed. In cases with molecular characteristics favoring response to immunotherapy, an optimal sequencing approach may incorporate an initial run-in phase with immunotherapy to determine if symptom palliation can be achieved with unimodal therapy. The location of the mass in a non-radiation sensitive region allowed us to entertain the use of combination therapy for our patient, but ultimately was not needed. Palliative RT will remain an option at the time of cancer progression.
Chimeric Antigen Receptor T-cell Therapy in the Veterans Affairs Network: the Tennessee Valley Healthcare System Experience
Purpose/Background
Chimeric antigen receptor T-cell (CART) therapy has emerged as a novel treatment for hematologic malignancies, with six FDA agents approved for commercial use. The Veterans Affairs (VA) Tennessee Valley Healthcare System (TVHS) is the only VA facility authorized to administer CART therapy. As these therapies are changing the paradigm of treatment, the purpose of this review will report the TVHS experience thus far.
Methods
TVHS began coordination with pharmaceutical manufacturers of CART therapies upon first approval in 2017 and became an authorized treatment center for CART therapy in September 2019 with the first CART infusion performed in December of that year. This is a retrospective electronic chart review of all CART patients referred to TVHS from the program’s inception, December 1, 2019 through June 30, 2021. The primary objective of this analysis will be to evaluate the efficacy outcomes of veterans who received CART therapy at TVHS, including overall response rates (ORR), progression free survival (PFS), and overall survival (OS). Secondary objectives include assessment of toxicities, including rates and maximum grades of cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS).
Results
A total of 28 patients have received CART infusion at TVHS to date. Fifteen of these patients have reached one year post-CART infusion and are included in this analysis. The majority of patients were White (67%) and were treated for diffuse large B-cell lymphoma (87%). All patients were male and ten (67%) were over the age of 65. ORR was 93% (73% achieved complete response [CR]). One-year PFS and OS were both 60%. Of patients who achieved CR by day 100, 89% remain in CR to date. CRS toxicity was observed in 73% of patients (no Grade 3 or higher). ICANS was observed in 26.7% of patients (20% Grade 3 or higher).
Conclusions
CART therapy within the VA has become a well-established practice at TVHS and appears to be a safe and effective therapeutic option for veterans with aggressive lymphoid malignancies.
Purpose/Background
Chimeric antigen receptor T-cell (CART) therapy has emerged as a novel treatment for hematologic malignancies, with six FDA agents approved for commercial use. The Veterans Affairs (VA) Tennessee Valley Healthcare System (TVHS) is the only VA facility authorized to administer CART therapy. As these therapies are changing the paradigm of treatment, the purpose of this review will report the TVHS experience thus far.
Methods
TVHS began coordination with pharmaceutical manufacturers of CART therapies upon first approval in 2017 and became an authorized treatment center for CART therapy in September 2019 with the first CART infusion performed in December of that year. This is a retrospective electronic chart review of all CART patients referred to TVHS from the program’s inception, December 1, 2019 through June 30, 2021. The primary objective of this analysis will be to evaluate the efficacy outcomes of veterans who received CART therapy at TVHS, including overall response rates (ORR), progression free survival (PFS), and overall survival (OS). Secondary objectives include assessment of toxicities, including rates and maximum grades of cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS).
Results
A total of 28 patients have received CART infusion at TVHS to date. Fifteen of these patients have reached one year post-CART infusion and are included in this analysis. The majority of patients were White (67%) and were treated for diffuse large B-cell lymphoma (87%). All patients were male and ten (67%) were over the age of 65. ORR was 93% (73% achieved complete response [CR]). One-year PFS and OS were both 60%. Of patients who achieved CR by day 100, 89% remain in CR to date. CRS toxicity was observed in 73% of patients (no Grade 3 or higher). ICANS was observed in 26.7% of patients (20% Grade 3 or higher).
Conclusions
CART therapy within the VA has become a well-established practice at TVHS and appears to be a safe and effective therapeutic option for veterans with aggressive lymphoid malignancies.
Purpose/Background
Chimeric antigen receptor T-cell (CART) therapy has emerged as a novel treatment for hematologic malignancies, with six FDA agents approved for commercial use. The Veterans Affairs (VA) Tennessee Valley Healthcare System (TVHS) is the only VA facility authorized to administer CART therapy. As these therapies are changing the paradigm of treatment, the purpose of this review will report the TVHS experience thus far.
Methods
TVHS began coordination with pharmaceutical manufacturers of CART therapies upon first approval in 2017 and became an authorized treatment center for CART therapy in September 2019 with the first CART infusion performed in December of that year. This is a retrospective electronic chart review of all CART patients referred to TVHS from the program’s inception, December 1, 2019 through June 30, 2021. The primary objective of this analysis will be to evaluate the efficacy outcomes of veterans who received CART therapy at TVHS, including overall response rates (ORR), progression free survival (PFS), and overall survival (OS). Secondary objectives include assessment of toxicities, including rates and maximum grades of cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS).
Results
A total of 28 patients have received CART infusion at TVHS to date. Fifteen of these patients have reached one year post-CART infusion and are included in this analysis. The majority of patients were White (67%) and were treated for diffuse large B-cell lymphoma (87%). All patients were male and ten (67%) were over the age of 65. ORR was 93% (73% achieved complete response [CR]). One-year PFS and OS were both 60%. Of patients who achieved CR by day 100, 89% remain in CR to date. CRS toxicity was observed in 73% of patients (no Grade 3 or higher). ICANS was observed in 26.7% of patients (20% Grade 3 or higher).
Conclusions
CART therapy within the VA has become a well-established practice at TVHS and appears to be a safe and effective therapeutic option for veterans with aggressive lymphoid malignancies.
After index colonoscopy, what’s the CRC risk in 40- to 49-year-olds vs. 50- to 59-year-olds?
New data suggest that for individuals who do not have an adenoma detected on an index colonoscopy, the risk of developing an advanced neoplasia (AN) and colorectal cancer (CRC) is lower in those who are aged 40-49 years, compared with those who are 50-59 years old.
However, there is no difference between the two age groups in detection rates of nonadvanced adenoma (NAA) or advanced adenoma (AA), the same study found.
“The primary goal of this study was to investigate the risk of metachronous AN associated with conventional adenoma detected on the index colonoscopy,” explain the authors, led by Gene Ma, MD, Kaiser Permanente Northern California, San Jose.
“The lack of good-quality evidence to inform surveillance in the 40-49 year old population has resulted in inconsistent surveillance patterns in clinical practice, leading to variation in the quality of care, including both inadequate and excessive colonoscopic surveillance,” Dr. Ma and colleagues observe.
The findings from this study “expand our understanding of the risk of AN and CRC in younger individuals and suggest that the current multi-society guidelines for surveillance may be applicable for individuals 40-49 years of age,” the authors conclude.
The study was published online in The American Journal of Gastroenterology, and included 2,396 individuals between 40 and 49 years of age and 8,978 individuals between 50 and 59 years of age.
The colonoscopy was carried out for screening in 40.2% in the younger age group versus 34.8% in the older age group and was prompted by a positive fecal immunochemical test in 3.3% of the younger age group versus 32% of the older age group.
The median follow-up for both age groups was roughly 7 years.
“When comparing the 40-49 years group to the 50-59 years group, index colonoscopy detected no adenoma in 62.9% versus 40.1% (P < .0001); NAA in 25.4% versus 39.0% (P <.001), and AA in 11.6% versus 21.0% (P < .0001), respectively,” Dr. Ma and colleagues report.
When the two age groups were compared for surveillance colonoscopy, no adenoma was detected in 67% of the younger age group versus 54.7% of the older age group (P < .0001), whereas NAA was detected in 25.4% of the 40- to 49-year-olds versus 38.4% of the 50- to 59-year-olds (P < .0001). AA was detected in 3.5% versus 6.95 (P < .0001) of persons in each of the two age groups, respectively.
AN was detected on surveillance colonoscopy after index colonoscopy in 2.2% of the younger age group and twice that percentage, at 4.4%, in the older age group (P = .0003). On surveillance colonoscopy, NAA was found in 4.6% of the younger age group, compared with 7% of the older age group (P = .03), whereas AA was found in 7.9% of the 40- to 49-year-olds, compared with 11.7% of the 50- to 59-year-olds (P = .06).
The median time until surveillance colonoscopy was similar in both age groups when either NAA or AA was found on index colonoscopy, the authors note. In addition, the median time until the detection of AN was similar whether NAA or AA was detected on index colonoscopy, they add.
The overall crude cumulative incidence of AN was lower in the younger age group when no adenoma was detected on index colonoscopy (P = .0003) as well as when NAA was detected, which would be consistent with recommendations from current guidelines for surveillance colonoscopy after adenoma detection. However, there was no difference between the two age groups in the overall cumulative incidence of AN when AA was detected on index colonoscopy.
Overall, the risk for metachronous AN in persons aged 40-49 years was lower when no adenoma was detected on index colonoscopy, but there was no difference between the two age groups when NAA or AA was detected again on index colonoscopy. Similarly, those aged 40-49 years of age had a lower risk for AA or CRC when no adenoma was detected on index colonoscopy – but again, there was no difference in the risk for AA or CRC when either NAA or AA was detected on index colonoscopy.
The authors have no conflicts of interest to report.
A version of this article first appeared on Medscape.com.
New data suggest that for individuals who do not have an adenoma detected on an index colonoscopy, the risk of developing an advanced neoplasia (AN) and colorectal cancer (CRC) is lower in those who are aged 40-49 years, compared with those who are 50-59 years old.
However, there is no difference between the two age groups in detection rates of nonadvanced adenoma (NAA) or advanced adenoma (AA), the same study found.
“The primary goal of this study was to investigate the risk of metachronous AN associated with conventional adenoma detected on the index colonoscopy,” explain the authors, led by Gene Ma, MD, Kaiser Permanente Northern California, San Jose.
“The lack of good-quality evidence to inform surveillance in the 40-49 year old population has resulted in inconsistent surveillance patterns in clinical practice, leading to variation in the quality of care, including both inadequate and excessive colonoscopic surveillance,” Dr. Ma and colleagues observe.
The findings from this study “expand our understanding of the risk of AN and CRC in younger individuals and suggest that the current multi-society guidelines for surveillance may be applicable for individuals 40-49 years of age,” the authors conclude.
The study was published online in The American Journal of Gastroenterology, and included 2,396 individuals between 40 and 49 years of age and 8,978 individuals between 50 and 59 years of age.
The colonoscopy was carried out for screening in 40.2% in the younger age group versus 34.8% in the older age group and was prompted by a positive fecal immunochemical test in 3.3% of the younger age group versus 32% of the older age group.
The median follow-up for both age groups was roughly 7 years.
“When comparing the 40-49 years group to the 50-59 years group, index colonoscopy detected no adenoma in 62.9% versus 40.1% (P < .0001); NAA in 25.4% versus 39.0% (P <.001), and AA in 11.6% versus 21.0% (P < .0001), respectively,” Dr. Ma and colleagues report.
When the two age groups were compared for surveillance colonoscopy, no adenoma was detected in 67% of the younger age group versus 54.7% of the older age group (P < .0001), whereas NAA was detected in 25.4% of the 40- to 49-year-olds versus 38.4% of the 50- to 59-year-olds (P < .0001). AA was detected in 3.5% versus 6.95 (P < .0001) of persons in each of the two age groups, respectively.
AN was detected on surveillance colonoscopy after index colonoscopy in 2.2% of the younger age group and twice that percentage, at 4.4%, in the older age group (P = .0003). On surveillance colonoscopy, NAA was found in 4.6% of the younger age group, compared with 7% of the older age group (P = .03), whereas AA was found in 7.9% of the 40- to 49-year-olds, compared with 11.7% of the 50- to 59-year-olds (P = .06).
The median time until surveillance colonoscopy was similar in both age groups when either NAA or AA was found on index colonoscopy, the authors note. In addition, the median time until the detection of AN was similar whether NAA or AA was detected on index colonoscopy, they add.
The overall crude cumulative incidence of AN was lower in the younger age group when no adenoma was detected on index colonoscopy (P = .0003) as well as when NAA was detected, which would be consistent with recommendations from current guidelines for surveillance colonoscopy after adenoma detection. However, there was no difference between the two age groups in the overall cumulative incidence of AN when AA was detected on index colonoscopy.
Overall, the risk for metachronous AN in persons aged 40-49 years was lower when no adenoma was detected on index colonoscopy, but there was no difference between the two age groups when NAA or AA was detected again on index colonoscopy. Similarly, those aged 40-49 years of age had a lower risk for AA or CRC when no adenoma was detected on index colonoscopy – but again, there was no difference in the risk for AA or CRC when either NAA or AA was detected on index colonoscopy.
The authors have no conflicts of interest to report.
A version of this article first appeared on Medscape.com.
New data suggest that for individuals who do not have an adenoma detected on an index colonoscopy, the risk of developing an advanced neoplasia (AN) and colorectal cancer (CRC) is lower in those who are aged 40-49 years, compared with those who are 50-59 years old.
However, there is no difference between the two age groups in detection rates of nonadvanced adenoma (NAA) or advanced adenoma (AA), the same study found.
“The primary goal of this study was to investigate the risk of metachronous AN associated with conventional adenoma detected on the index colonoscopy,” explain the authors, led by Gene Ma, MD, Kaiser Permanente Northern California, San Jose.
“The lack of good-quality evidence to inform surveillance in the 40-49 year old population has resulted in inconsistent surveillance patterns in clinical practice, leading to variation in the quality of care, including both inadequate and excessive colonoscopic surveillance,” Dr. Ma and colleagues observe.
The findings from this study “expand our understanding of the risk of AN and CRC in younger individuals and suggest that the current multi-society guidelines for surveillance may be applicable for individuals 40-49 years of age,” the authors conclude.
The study was published online in The American Journal of Gastroenterology, and included 2,396 individuals between 40 and 49 years of age and 8,978 individuals between 50 and 59 years of age.
The colonoscopy was carried out for screening in 40.2% in the younger age group versus 34.8% in the older age group and was prompted by a positive fecal immunochemical test in 3.3% of the younger age group versus 32% of the older age group.
The median follow-up for both age groups was roughly 7 years.
“When comparing the 40-49 years group to the 50-59 years group, index colonoscopy detected no adenoma in 62.9% versus 40.1% (P < .0001); NAA in 25.4% versus 39.0% (P <.001), and AA in 11.6% versus 21.0% (P < .0001), respectively,” Dr. Ma and colleagues report.
When the two age groups were compared for surveillance colonoscopy, no adenoma was detected in 67% of the younger age group versus 54.7% of the older age group (P < .0001), whereas NAA was detected in 25.4% of the 40- to 49-year-olds versus 38.4% of the 50- to 59-year-olds (P < .0001). AA was detected in 3.5% versus 6.95 (P < .0001) of persons in each of the two age groups, respectively.
AN was detected on surveillance colonoscopy after index colonoscopy in 2.2% of the younger age group and twice that percentage, at 4.4%, in the older age group (P = .0003). On surveillance colonoscopy, NAA was found in 4.6% of the younger age group, compared with 7% of the older age group (P = .03), whereas AA was found in 7.9% of the 40- to 49-year-olds, compared with 11.7% of the 50- to 59-year-olds (P = .06).
The median time until surveillance colonoscopy was similar in both age groups when either NAA or AA was found on index colonoscopy, the authors note. In addition, the median time until the detection of AN was similar whether NAA or AA was detected on index colonoscopy, they add.
The overall crude cumulative incidence of AN was lower in the younger age group when no adenoma was detected on index colonoscopy (P = .0003) as well as when NAA was detected, which would be consistent with recommendations from current guidelines for surveillance colonoscopy after adenoma detection. However, there was no difference between the two age groups in the overall cumulative incidence of AN when AA was detected on index colonoscopy.
Overall, the risk for metachronous AN in persons aged 40-49 years was lower when no adenoma was detected on index colonoscopy, but there was no difference between the two age groups when NAA or AA was detected again on index colonoscopy. Similarly, those aged 40-49 years of age had a lower risk for AA or CRC when no adenoma was detected on index colonoscopy – but again, there was no difference in the risk for AA or CRC when either NAA or AA was detected on index colonoscopy.
The authors have no conflicts of interest to report.
A version of this article first appeared on Medscape.com.
FROM THE AMERICAN JOURNAL OF GASTROENTEROLOGY
Pivotal trials in blood cancers don’t mirror patient populations
, a new study concludes.
“Our analysis shows that, over the past 10 years, participation in pivotal clinical trials investigating therapies for leukemias and MM is unrepresentative of the U.S. population,” say the authors, led by Jorge E. Cortes, MD, of the Georgia Cancer Center at Augusta University, Ga. “Trials should represent the population with the disease,” they comment.
The study was published in the Journal of Clinical Oncology.
“This study confirms that the U.S. cancer population for select hematologic malignancies was inadequately racially and ethnically represented in studies leading to drug approval,” comment the authors of an accompanying editorial.
“The results from this study should lead to questions about the generalizability of drug safety and efficacy in populations we serve as medical hematologists and oncologists,” say Mikkael A. Sekeres, MD, along with Namrata S. Chandhok, MD, both of the division of hematology, Sylvester Comprehensive Cancer Center, University of Miami.
They pose the question, for instance, as physicians practicing in South Florida, where most of their patients are Hispanic, “can we apply the results of these pivotal studies – and drug labels – to them, without any sense of whether they metabolize the drug the same way as those included in the study or have the same biologic targets?”
Analysis of pivotal trials
For their study, Dr. Cortes and colleagues analyzed 61 pivotal trials for leukemia and MM leading to approval of the drugs from the U.S. Food and Drug Administration between 2011 and 2021.
They found that only two-thirds (67.2%) of these trials reported data pertaining to race, while about half (48.8%) reported on ethnicity.
The trials that did report data on race involved a total of 13,731 patients. The vast majority (81.6%) were White, and Black patients represented only 3.8%. Asian/Pacific Islanders made up 9.1%, and American Indians or Alaskan Natives made up just 0.12% of participants, with 1.5% categorized as other.
Among the trials reporting on ethnicity, 4.7% of patients were Hispanic, with 11.5% being Hispanic in acute lymphoblastic leukemia (ALL) trials and 7.6% Hispanic in chronic myeloid leukemia (CML) trials.
Slightly more than half (54.8%) of all trial participants were male, and patients’ average ages ranged from 41.7 to 67.3 years across all malignancies.
Of the minority groups, Asian/Pacific Islanders and Black people had the highest representation in trials involving CML, at 12.7% and 5.3%, respectively.
Their lowest representation was in chronic lymphocytic leukemia (CLL), at 3% and 1.1%, respectively.
Among the trials reporting ethnicity, Hispanic people were the highest representation, with percentages ranging from 3.8% of MM trials to 11.5% in ALL trials.
Inconsistent with patient populations
Next, the researchers compared the proportions of race/ethnic groups that were found among the participants of these pivotal trials with the proportions that would be expected in patient populations for each of these blood cancers (according to the U.S. Surveillance, Epidemiology, and End Results [SEER] database).
For example, White people made up 80.3% of participants in clinical trials of MM, whereas they represent 68.7% of patients with MM, a difference that was statistically significant (P < .0001).
The finding was similar for CML, with White people accounting for 90.5% of participants in clinical trials versus 82.5% of the patient population (P < .0001).
For AML, the difference was smaller, with respective percentages of 79.6 versus 77.3% (P = .0389).
For Black people, Asian/Pacific Islanders and Hispanic people, across all five cancer types that were analyzed, the proportion of participants in clinical trials was significantly lower than the proportion in the patient population.
The analysis also showed that females were overrepresented in clinical trials for two blood cancers. For MM, trial participation was 44.7%, while disease incidence was 41.7% (P < .0001), and for CML the proportions were 44.7% versus 39.5% (P = .0009). However, females were underrepresented in a third blood cancer: in AML, the proportions were 44.7% versus 60.5% (P < .0001).
Geographic location of trials often inaccessible
The study also highlighted an obstacle to minorities participating in clinical trials: geography.
For this analysis, the researchers looked at mortality rates for the various blood cancers.
For AML, they found mortality rates were high across the whole of the United States, but centers conducting AML clinical trials were primarily in the Northeast, with no centers in the Midwest.
Key regions with high rates of AML mortality, low access to trials, and high minority representation were notably clustered in areas including east of the Carolinas, South Georgia, Alabama, and Mississippi, the authors noted.
“In many instances, trials were absent in areas with high mortality,” they report. “This makes access to clinical trials difficult, if not impossible, to patients who do not have the financial means for travel.”
Further action needed
Racial and ethnic disparities in clinical trials have been widely reported in numerous previous studies, the authors note.
Various initiatives have been launched in recent years to tackle the problem, including the National Institutes of Health Revitalization Act, FDA race and ethnicity guidance, and the International Conference for Harmonization guidance.
For oncology, the American Society of Clinical Oncology has also taken steps with the release of the new Equity, Diversity, and Inclusion Action Plan in 2021 to improve representation of minorities in research.
Dr. Cortes and colleagues suggest another step that is needed is standardized reporting of demographics of clinical trial participants.
“More importantly, efforts to increase representation of minorities and disadvantaged populations in clinical trials should be prioritized,” they say.
Dr. Cortes reports a consulting role and receiving research funding from many pharmaceutical companies. No other coauthors have financial disclosures. Dr. Chandhok reports honoraria from Healio, Clinical Care Options, and a consulting role with Servier. Dr. Sekeres reports a consulting role with Celgene, Millennium, Pfizer, Novartis, Syros Pharmaceuticals, Kurome Therapeutics, and institutional research funding from Takeda, Pfizer, Bristol Myers Squibb, Actuate Therapeutics, Sellas Life Sciences, and Bio-Path Holdings.
A version of this article first appeared on Medscape.com.
, a new study concludes.
“Our analysis shows that, over the past 10 years, participation in pivotal clinical trials investigating therapies for leukemias and MM is unrepresentative of the U.S. population,” say the authors, led by Jorge E. Cortes, MD, of the Georgia Cancer Center at Augusta University, Ga. “Trials should represent the population with the disease,” they comment.
The study was published in the Journal of Clinical Oncology.
“This study confirms that the U.S. cancer population for select hematologic malignancies was inadequately racially and ethnically represented in studies leading to drug approval,” comment the authors of an accompanying editorial.
“The results from this study should lead to questions about the generalizability of drug safety and efficacy in populations we serve as medical hematologists and oncologists,” say Mikkael A. Sekeres, MD, along with Namrata S. Chandhok, MD, both of the division of hematology, Sylvester Comprehensive Cancer Center, University of Miami.
They pose the question, for instance, as physicians practicing in South Florida, where most of their patients are Hispanic, “can we apply the results of these pivotal studies – and drug labels – to them, without any sense of whether they metabolize the drug the same way as those included in the study or have the same biologic targets?”
Analysis of pivotal trials
For their study, Dr. Cortes and colleagues analyzed 61 pivotal trials for leukemia and MM leading to approval of the drugs from the U.S. Food and Drug Administration between 2011 and 2021.
They found that only two-thirds (67.2%) of these trials reported data pertaining to race, while about half (48.8%) reported on ethnicity.
The trials that did report data on race involved a total of 13,731 patients. The vast majority (81.6%) were White, and Black patients represented only 3.8%. Asian/Pacific Islanders made up 9.1%, and American Indians or Alaskan Natives made up just 0.12% of participants, with 1.5% categorized as other.
Among the trials reporting on ethnicity, 4.7% of patients were Hispanic, with 11.5% being Hispanic in acute lymphoblastic leukemia (ALL) trials and 7.6% Hispanic in chronic myeloid leukemia (CML) trials.
Slightly more than half (54.8%) of all trial participants were male, and patients’ average ages ranged from 41.7 to 67.3 years across all malignancies.
Of the minority groups, Asian/Pacific Islanders and Black people had the highest representation in trials involving CML, at 12.7% and 5.3%, respectively.
Their lowest representation was in chronic lymphocytic leukemia (CLL), at 3% and 1.1%, respectively.
Among the trials reporting ethnicity, Hispanic people were the highest representation, with percentages ranging from 3.8% of MM trials to 11.5% in ALL trials.
Inconsistent with patient populations
Next, the researchers compared the proportions of race/ethnic groups that were found among the participants of these pivotal trials with the proportions that would be expected in patient populations for each of these blood cancers (according to the U.S. Surveillance, Epidemiology, and End Results [SEER] database).
For example, White people made up 80.3% of participants in clinical trials of MM, whereas they represent 68.7% of patients with MM, a difference that was statistically significant (P < .0001).
The finding was similar for CML, with White people accounting for 90.5% of participants in clinical trials versus 82.5% of the patient population (P < .0001).
For AML, the difference was smaller, with respective percentages of 79.6 versus 77.3% (P = .0389).
For Black people, Asian/Pacific Islanders and Hispanic people, across all five cancer types that were analyzed, the proportion of participants in clinical trials was significantly lower than the proportion in the patient population.
The analysis also showed that females were overrepresented in clinical trials for two blood cancers. For MM, trial participation was 44.7%, while disease incidence was 41.7% (P < .0001), and for CML the proportions were 44.7% versus 39.5% (P = .0009). However, females were underrepresented in a third blood cancer: in AML, the proportions were 44.7% versus 60.5% (P < .0001).
Geographic location of trials often inaccessible
The study also highlighted an obstacle to minorities participating in clinical trials: geography.
For this analysis, the researchers looked at mortality rates for the various blood cancers.
For AML, they found mortality rates were high across the whole of the United States, but centers conducting AML clinical trials were primarily in the Northeast, with no centers in the Midwest.
Key regions with high rates of AML mortality, low access to trials, and high minority representation were notably clustered in areas including east of the Carolinas, South Georgia, Alabama, and Mississippi, the authors noted.
“In many instances, trials were absent in areas with high mortality,” they report. “This makes access to clinical trials difficult, if not impossible, to patients who do not have the financial means for travel.”
Further action needed
Racial and ethnic disparities in clinical trials have been widely reported in numerous previous studies, the authors note.
Various initiatives have been launched in recent years to tackle the problem, including the National Institutes of Health Revitalization Act, FDA race and ethnicity guidance, and the International Conference for Harmonization guidance.
For oncology, the American Society of Clinical Oncology has also taken steps with the release of the new Equity, Diversity, and Inclusion Action Plan in 2021 to improve representation of minorities in research.
Dr. Cortes and colleagues suggest another step that is needed is standardized reporting of demographics of clinical trial participants.
“More importantly, efforts to increase representation of minorities and disadvantaged populations in clinical trials should be prioritized,” they say.
Dr. Cortes reports a consulting role and receiving research funding from many pharmaceutical companies. No other coauthors have financial disclosures. Dr. Chandhok reports honoraria from Healio, Clinical Care Options, and a consulting role with Servier. Dr. Sekeres reports a consulting role with Celgene, Millennium, Pfizer, Novartis, Syros Pharmaceuticals, Kurome Therapeutics, and institutional research funding from Takeda, Pfizer, Bristol Myers Squibb, Actuate Therapeutics, Sellas Life Sciences, and Bio-Path Holdings.
A version of this article first appeared on Medscape.com.
, a new study concludes.
“Our analysis shows that, over the past 10 years, participation in pivotal clinical trials investigating therapies for leukemias and MM is unrepresentative of the U.S. population,” say the authors, led by Jorge E. Cortes, MD, of the Georgia Cancer Center at Augusta University, Ga. “Trials should represent the population with the disease,” they comment.
The study was published in the Journal of Clinical Oncology.
“This study confirms that the U.S. cancer population for select hematologic malignancies was inadequately racially and ethnically represented in studies leading to drug approval,” comment the authors of an accompanying editorial.
“The results from this study should lead to questions about the generalizability of drug safety and efficacy in populations we serve as medical hematologists and oncologists,” say Mikkael A. Sekeres, MD, along with Namrata S. Chandhok, MD, both of the division of hematology, Sylvester Comprehensive Cancer Center, University of Miami.
They pose the question, for instance, as physicians practicing in South Florida, where most of their patients are Hispanic, “can we apply the results of these pivotal studies – and drug labels – to them, without any sense of whether they metabolize the drug the same way as those included in the study or have the same biologic targets?”
Analysis of pivotal trials
For their study, Dr. Cortes and colleagues analyzed 61 pivotal trials for leukemia and MM leading to approval of the drugs from the U.S. Food and Drug Administration between 2011 and 2021.
They found that only two-thirds (67.2%) of these trials reported data pertaining to race, while about half (48.8%) reported on ethnicity.
The trials that did report data on race involved a total of 13,731 patients. The vast majority (81.6%) were White, and Black patients represented only 3.8%. Asian/Pacific Islanders made up 9.1%, and American Indians or Alaskan Natives made up just 0.12% of participants, with 1.5% categorized as other.
Among the trials reporting on ethnicity, 4.7% of patients were Hispanic, with 11.5% being Hispanic in acute lymphoblastic leukemia (ALL) trials and 7.6% Hispanic in chronic myeloid leukemia (CML) trials.
Slightly more than half (54.8%) of all trial participants were male, and patients’ average ages ranged from 41.7 to 67.3 years across all malignancies.
Of the minority groups, Asian/Pacific Islanders and Black people had the highest representation in trials involving CML, at 12.7% and 5.3%, respectively.
Their lowest representation was in chronic lymphocytic leukemia (CLL), at 3% and 1.1%, respectively.
Among the trials reporting ethnicity, Hispanic people were the highest representation, with percentages ranging from 3.8% of MM trials to 11.5% in ALL trials.
Inconsistent with patient populations
Next, the researchers compared the proportions of race/ethnic groups that were found among the participants of these pivotal trials with the proportions that would be expected in patient populations for each of these blood cancers (according to the U.S. Surveillance, Epidemiology, and End Results [SEER] database).
For example, White people made up 80.3% of participants in clinical trials of MM, whereas they represent 68.7% of patients with MM, a difference that was statistically significant (P < .0001).
The finding was similar for CML, with White people accounting for 90.5% of participants in clinical trials versus 82.5% of the patient population (P < .0001).
For AML, the difference was smaller, with respective percentages of 79.6 versus 77.3% (P = .0389).
For Black people, Asian/Pacific Islanders and Hispanic people, across all five cancer types that were analyzed, the proportion of participants in clinical trials was significantly lower than the proportion in the patient population.
The analysis also showed that females were overrepresented in clinical trials for two blood cancers. For MM, trial participation was 44.7%, while disease incidence was 41.7% (P < .0001), and for CML the proportions were 44.7% versus 39.5% (P = .0009). However, females were underrepresented in a third blood cancer: in AML, the proportions were 44.7% versus 60.5% (P < .0001).
Geographic location of trials often inaccessible
The study also highlighted an obstacle to minorities participating in clinical trials: geography.
For this analysis, the researchers looked at mortality rates for the various blood cancers.
For AML, they found mortality rates were high across the whole of the United States, but centers conducting AML clinical trials were primarily in the Northeast, with no centers in the Midwest.
Key regions with high rates of AML mortality, low access to trials, and high minority representation were notably clustered in areas including east of the Carolinas, South Georgia, Alabama, and Mississippi, the authors noted.
“In many instances, trials were absent in areas with high mortality,” they report. “This makes access to clinical trials difficult, if not impossible, to patients who do not have the financial means for travel.”
Further action needed
Racial and ethnic disparities in clinical trials have been widely reported in numerous previous studies, the authors note.
Various initiatives have been launched in recent years to tackle the problem, including the National Institutes of Health Revitalization Act, FDA race and ethnicity guidance, and the International Conference for Harmonization guidance.
For oncology, the American Society of Clinical Oncology has also taken steps with the release of the new Equity, Diversity, and Inclusion Action Plan in 2021 to improve representation of minorities in research.
Dr. Cortes and colleagues suggest another step that is needed is standardized reporting of demographics of clinical trial participants.
“More importantly, efforts to increase representation of minorities and disadvantaged populations in clinical trials should be prioritized,” they say.
Dr. Cortes reports a consulting role and receiving research funding from many pharmaceutical companies. No other coauthors have financial disclosures. Dr. Chandhok reports honoraria from Healio, Clinical Care Options, and a consulting role with Servier. Dr. Sekeres reports a consulting role with Celgene, Millennium, Pfizer, Novartis, Syros Pharmaceuticals, Kurome Therapeutics, and institutional research funding from Takeda, Pfizer, Bristol Myers Squibb, Actuate Therapeutics, Sellas Life Sciences, and Bio-Path Holdings.
A version of this article first appeared on Medscape.com.
FROM THE JOURNAL OF CLINICAL ONCOLOGY